HTA fluid level and fluid type measurement

ABSTRACT

Apparatus for measuring an amount of ablation fluid circulating in a system for ablating tissue comprises a plurality of electrical contacts located within an ablation fluid receiving chamber of the system, the contacts being located at various heights and a data processing arrangement coupled to the contacts to receive data corresponding to electrical conductance between pairs of the contacts, the data processing arrangement determining a height of fluid in the chamber based on the measured conductance levels and determining based on the determined height, whether an amount of fluid circulating through the system is within a desired range.

PRIORITY CLAIM

The present application is Continuation application of U.S. patentapplication Ser. No. 12/277,440 filed on Nov. 25, 2008, now U.S. Pat.No. 8,146,420; which claims the priority to U.S. Provisional ApplicationSerial No. 61/016,168 filed on Dec. 21, 2007. The entire disclosures ofthe above applications are expressly incorporated herein by reference.

BACKGROUND

Menorrhagia, excessive uterine bleeding during a prolonged menstrualperiod, has been attributed to disorders of the endometrium. Whilehysterectomies provides a definitive treatment for menorrhagia, lessinvasive procedures are attractive as they generally entail reduced sideeffects, shorter hospital stays and less procedural and post-operativediscomfort.

Generally, these less invasive procedures ablate tissue through theapplication of electrical energy (e.g., RF energy), heat (e.g., laser)or cryogenic temperatures. However, these procedures typically rely ondirect visualization of the uterus by an experienced operator to ablateselected portions of the endometrium. Alternatively, the entireendometrium may be treated by conduction uterine ablation, i.e.,circulating a heated fluid through the uterus. In certain of theseprocedures, the heated fluid may be contained within a balloon whilecirculating through the uterus while in others, the fluid directlycontacts the endometrium. These systems generally employ a resistiveelement to heat the ablation fluid (e.g., saline) to a temperaturewithin a desired range while maintaining the pressure of the circulatedfluid substantially constant.

SUMMARY OF THE INVENTION

The present invention is directed to an apparatus for measuring anamount of ablation fluid circulating in a system for ablating tissue,comprising a plurality of electrical contacts located within an ablationfluid receiving chamber of the system, the contacts being located atvarious heights and a data processing arrangement coupled to thecontacts to receive data corresponding to electrical conductance betweenpairs of the contacts, the data processing arrangement determining aheight of fluid in the chamber based on the measured conductance levelsand determining based on the determined height, whether an amount offluid circulating through the system is within a desired range.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first view of a first design for an exemplary embodimentof the present invention;

FIG. 2 shows a second view of a first design for an exemplary embodimentof the present invention.

FIG. 3 shows a first design for a second exemplary embodiment of thepresent invention.

FIG. 4 shows the circuitry for a second exemplary embodiment of thepresent invention.

FIG. 5 details the method of the second exemplary embodiment of thepresent invention.

DETAILED DESCRIPTION

The present invention may be further understood with reference to thefollowing description and the appended drawings. Although the presentinvention relates to systems and methods for measuring fluid level anddetecting fluid properties within a device for thermally ablating theendometrium, the devices and methods according to the present inventionand components thereof may be utilized in conjunction with systems forprostate treatment (microwave or cryoablation), irrigation systems orany other fluid ablation devices.

Thermal ablation is more safe, effective and efficient when flow leveland pressure within the hollow organ are precisely controlled to desiredlevels. As those skilled in the art will understand, the exact values offlow levels and pressures may vary in accordance with, for example,patient conditions, the procedure to be performed, etc.

The present invention employs a processing unit comprising a set ofelements which, when operating in conjunction with one another,accurately measure a level and detect a type of fluid circulating withina thermal ablation system. For example, one such system is described inthe U.S. Patent Application Ser. No. 60/987,913, entitled “ThermalAblation System”, naming as inventors Robert J. Bouthillier, Michael P.Fusaro, Joseph M. Gordon, Stephen S. Keaney, Brian MacLean, Andrew W.Marsella, David Robson and Boris Shapeton filed on Nov. 14, 2007. Theentire disclosure of this application is hereby incorporated byreference herein. As shown in FIGS. 1 and 2, a Conductive Level Sensor200 according to a first exemplary embodiment of the invention issituated, for example, on a surface of a printed circuit board (“PCB”)204. As would be understood by those skilled in the art, the ConductiveLevel Sensor 200 may be formed as a separate chip or incorporated into aprocessing unit also comprising a microprocessor or other dataprocessing arrangement.

The ablation system according to this embodiment is a closed loop systemfor recirculating fluid from the apparatus into the uterus and back tothe system with the Conductive Level Sensor 200 located within a fluidchamber (not shown) of the ablation system. The Conductive Level Sensor200 is arranged vertically so that, as the amount of ablation fluidcirculating through the system varies, the level of fluid in the chamberrises and falls moving an upper surface of the fluid up and down thesurface of the Conductive Level Sensor 200. As will be described in moredetail below, the Conductive Level Sensor 200 detects the level of thefluid in the chamber and the conductivity of the ablation fluid, TheConductive Level Sensor 200 or a separate processing unit then comparesthe detected fluid level and conductivity to desired values or desiredranges of values and takes actions based on the comparison.

The Conductive Level Sensor 200 includes a plurality of contacts 205(e.g., gold-plated contacts) which are formed in an array substantiallyuniformly spaced in vertical columns along front and back surfaces 201,202, respectively of the PCB 204. However, those skilled in the art willunderstand that the contacts 205 may be formed of any other suitableconductive material and arranged in any desired pattern at selectedheights corresponding to various amounts of fluid circulating throughthe system. For example, depending on the geometry of the fluid chamberwithin which the PCB 204 is arranged, changes in the height of the uppersurface of the ablation fluid may correspond to varying volumetricdifferences along the height of the PCB 204. In such a case it may bedesirable to space the contacts 205 vertically at locationscorresponding to equal volumetric differences. The contacts 205 arearranged in lines adjacent to left and right edges of the PCB 204 andeach have a diameter of approximately 0.02 inches. Vertical columns ofthe contacts 205 spaced from one another by a length X₁ of approximately0.02 inches. The contacts 205 are vertically spaced from adjacentcontacts 205 by a length X₂ of approximately 0.05 inches Furthermore,the vertical columns 210 are horizontally spaced a length X₃ ofapproximately 0.06 inches from one another. Those skilled in the artwill understand that the vertical spacing of the contacts 205 determinesthe resolution of the measurement—i.e., the minimum system volumedifferential which can be detected.

Furthermore, as described in more detail below, by staggering thecontacts 205 in the two columns so that contacts in the left hand columnare vertically between contacts 205 of the right hand column, theresolution is further increased. The contacts 205 are also preferablysituated on front 201 and rear 202 sides of the PCB 204 in order toavoid film effects, as would be understood by those skilled in the art.

As described above, the contacts 205 are conductive, allowing theprocessing arrangement to utilize an array of analog switches to measurethe conductivity between pairs of the contacts 205 with the ablationfluid (e.g., saline) serving as a conductor. The conductivitymeasurements provided by the Conductive Level Sensor 200 may thereby beemployed by the processing arrangement to determine properties of thefluid circulating through the system. Specifically, the processingarrangement correlates the measured conductivity reading to a baselineconductivity value (or range of values) associated with desiredproperties of the ablation fluid (e.g., level of salinity), If themeasured conductivity value falls outside of the acceptable range, theprocessing arrangement may determine that a fluid other than the desiredfluid has been introduced into the system. Accordingly, whenconductivity ranges detected for the ablation fluid fall outside apredetermined range, the system may generate an alert to a userindicating that the proper fluid has not been supplied. Alternatively,when such a condition is detected, the system may execute a safeprocedure (e.g., terminating the procedure or suspending the procedureuntil a fluid having the desired properties is supplied).

As described above with respect to the front and rear sides 201, 202,respectively, of the Conductive Level Sensor 200, the exemplaryembodiment has two separate analog switch test paths measuringconductivity between pairs of the contacts 205 in a first direction A.The Conductive Level Sensor 200 employs at least two separate test pathsto allow for greater accuracy in the conductivity reading. Specifically,a first set of measurements may be made between corresponding sets ofconductors 205 located on the front side 201 and sets of conductorslocated on the rear side 202 adjacent a first edge 212 of the PCB 204.The first set of measurements may follow the direction A until each setof conductors has performed a measurement. A second set of measurementsmay be made between corresponding sets of conductors 205 located on thefront side 201 and sets of conductors located on the rear side 202adjacent a second edge 214 of the PCB 204, also in direction A. Thefirst and the second set of measurements may then be compared to oneanother by the processing arrangement to ensure the validity of thereadings. If the readings differ from one another by a value greaterthan a predetermined threshold, a user may be notified of the error orthe system may automatically execute a safety procedure.

Additionally, two test components may be situated between the at leasttwo analog switch test paths as described earlier to check the systemfor any or all of a plurality of errors including, among others, thedetection of a fluid other than saline as described above. A fault maybe indicated to the processing arrangement via a sequence of pulse-widthmodulated signals along a digital output line. The Conductive LevelSensor 200 may define different pulse sequences for each type of fault.For example, the Conductive Level Sensor 200 may define three pulsesequences: one pulse sequence for situations where fluid propertiesdetected correspond to those of the desired ablation fluid, a second forsituations where the detected fluid properties are outside the presetrange and a third pulse sequence signifying one or more other faults inthe system. Those skilled in the art will understand that variousalternate pulse sequences may be introduced without deviating from thescope of the present invention.

An alternate embodiment of the present invention employs a CapacitiveLevel Sensor 300 to detect the fluid level and fluid properties. TheCapacitive Level Sensor 300 is preferably seated within the manometer ofa disposable cassette of a thermal ablation device. That is, certainablation systems include a reusable console and a disposable cartridgewith all of the fluid contacting surfaces of the device being includedwithin the disposable cartridge so that the console may be reusedwithout the need for sterilization, etc. The Capacitive Level Sensor 300comprises a PCB which, when immersed in the manometer of the cassette ofthe thermal ablation device, is in contact with the saline fluid.Capacitive elements as shown in the circuit diagram of FIG. 4 are builtinto the PCB, which, for example, comprises a plurality of copper plates310 over a surface thereof. Accordingly, no external sensor elements arerequired as the capacitance may be measured through the conductivecopper of the copper plates 310. It is noted that although the exemplaryembodiment is described with respect to copper plates, any alternateconductive material may be used, as those skilled in the art willunderstand.

The Capacitive Level Sensor 300 measures changes in capacitance ofsensor strips 311 as fluid fills the cassette of the thermal ablationdevice and the level of the fluid moves up along the surface of the PCB.The change in capacitance is then used by a processing arrangement ofthe Capacitive Level Sensor 300 to determine the level of fluid in thecassette of the thermal ablation device and to determine, based on thislevel, an amount of fluid circulating through the system.

A Level-Sense Processor Board of the Capacitive Level Sensor 300 injectsa pulse into the ablation fluid and performs a synchronized measurementof the amplitude of the resulting waveform using a differentialamplifier. As shown in FIG. 5, the two inputs for the differentialamplifier may be Pulse A and Pulse B, as those skilled in the art willunderstand. The resulting waveform, L1, will be indicative of thecapacitance of the ablation fluid. Those skilled in the art willunderstand that the L1 value may include common-mode effects such asstray noise. Since this noise voltage is a common component of bothinput voltages Pulse A and Pulse B, the noise, indicated by L2, will becanceled out when a difference between the amplifier inputs is taken.The capacitance of the ablation fluid, L, may then be calculated usingthe formula L=L1−L2.

The resulting pulse waveform L (not shown) is then indicative of thecapacitance of the ablation fluid without noise interference. Thus, theL value indirectly indicates an amount of fluid present in the cassetteof the thermal ablation device which is directly related to the amountof fluid flowing through the system. As those skilled in the art willunderstand, if the amount of fluid in the cassette increases, the Lvalue increases proportionally. Accordingly, the L value may be used todetermine the amount of fluid in the cassette and determine therebywhether an obstruction is blocking fluid flow or there has been a lossof fluid (i.e., by absorption into the body or leakage), etc.

Those skilled in the art will understand that the capacitance of thefluid which directly affects the L value, may be affected by a number ofvariables including, but not limited to, the thickness of the CapacitiveLevel Sensor's 300 outer layer and the surface area of the externallyapplied copper plates 310 of the Capacitive Level Sensor 300.Accordingly, it is necessary to account for these values whendetermining the capacitance of the ablation fluid.

The capacitance of the externally applied plates 310 of the CapacitiveLevel Sensor 300 may be calculated in two steps. In the first step, thecapacitance of the empty Capacitive Level Sensor 300 may be calculatedusing the following formula:C ₁=(0.118*K ₁ A ₁)d ₁where C₁ refers to the capacitance, K₁ refers to the dielectric constantof an insulator situated between the copper plates 310 of the PCB andthe shielded portion 320 of the PCB, A₁ refers to the area of the copperplate 310 of the PCB in square inches and d₁ refers to the thickness ofthe insulator situated between the copper plates 310 and the shieldedportion 320. It is noted that there are no critical dimensions for thedistance between the sensor plates and the acceptable range and anyreasonably applicable range of distances may be utilized therein.

In a second step, the following formula may be used to calculate thecapacitance of the full sensor just prior to performing the thermalablation procedure:C ₂=(0.118*K ₂ A ₂)/d ₂ +C ₁where C₂ refers to the capacitance, K₂ refers to the dielectric constantof the cassette, A₂ refers to the area of the copper plate 310 in squareinches and d₂ refers to the thickness of the cassette.

As the amount of ablation fluid received in the cassette increases, theoverall capacitance changes. As would be understood by those skilled inthe art, that although this capacitance change is substantially linearwhen the plates are rectangular, the actual charging and discharging ofcapacitors is non-linear, due, in part, to factors including leakage,dissipation, manufacturing quality, equivalent series resistance,dielectric absorption, temperature dependence, etc. Accordingly, thesystem of the present invention is preferably altered to compensate forthe non-linearity of the Capacitive Level Sensor 300. One suchalteration may be the employment of tapered sensor plates rather thanrectangular sensor plates. Alternately, the system may utilize softwarelinearization, as those skilled in the art will understand.

The insulator situated between the sensor plates 310 and the shield 320may be composed of a plastic foam tape approximately 0.05 inches thickwith a copper plate area of 3.5 square inches. The cassette may becomposed of an Acrylonitrile Butadiene Styrene (“ABS”) plastic and havea thickness of 0.02 inches with a copper plate area of 3.5 squareinches.

The resolution of the Capacitive Level Sensor 300 is a function of themeasurement circuit, as shown in FIG. 4, and the capacitance range. Theexemplary embodiment, as described, may have a resolution ofapproximately 1 part in 100. The design of the circuit of the exemplaryembodiment of the present invention permits the fluctuation of thecapacitance range to one half its present range without impacting thesensor resolution.

The circuit of the Capacitive Level Sensor 300 measures the capacitanceregularly (e.g., approximately every 780 ms) and outputs a pulse-widthmodulated (“PWM”) signal having the same period. The PWM signal isfiltered with a 100 ms time constant, which settles within 500 ms, asthose skilled in the art will understand.

The power supply for the aforementioned circuit may be an Analog toDigital (“A/D”) converter that reads the sensor output in ratio-metricmode, as those skilled in the art will understand. Employment of theratio-metric mode may supply a resultant voltage that is a ratio of thereference voltage, which may be accomplished by using the referencevoltage as a source of excitation of the input voltage. By using aratio-metric mode, supply induced output voltage changes may be avoided,thereby adding a degree of stability to the power source.

The present invention has been described with reference to specificexemplary embodiments. Those skilled in the art will understand thatvarious modifications and changes may be made to the embodiments. Thespecifications are, therefore, to be regarded in an illustrative ratherthan a restrictive sense.

Those skilled in the art will understand that the described exemplaryembodiments of the present invention may be altered without departingfrom the spirit or scope of the invention. Thus, it is to be understoodthat these embodiments have been described in an exemplary manner andare not intended to limit the scope of the invention which is intendedto cover all modifications and variations of this invention that comewithin the scope of the appended claims and their equivalents.

What is claimed is:
 1. A device for measuring an amount of ablationfluid circulating in an ablation system, comprising: a printed circuitboard insertable into a fluid chamber of the ablation system and havinga first surface and a second surface; first and second contacts providedadjacent first and second edges of the first surface; third and fourthcontacts provided adjacent first and second edges of the second surface;and a data processing arrangement coupled to the printed circuit boardand configured to measure a first conductivity between the first andthird contacts and a second conductivity between the second and fourthcontacts, the data processing arrangement determining a fluid level ofthe ablation fluid based on a comparison of the first and secondconductivity measurements.
 2. The device of claim 1, wherein the dataprocessing arrangement is configured to indicate a fault if the firstconductivity measurement differs from the second conductivitymeasurement by a value exceeding a predetermined threshold.
 3. Thedevice of claim 2, wherein the data processing arrangement is configuredto output a pulse level sequence indicating a type of fault determinedby the comparison.
 4. The device of claim 1, wherein the data processingarrangement is configured to detect a fluid property of the fluid todetermine a presence of an unwanted fluid in the ablation system.
 5. Thedevice of claim 4, further comprising a first test component provided ina test path between the first and third contacts and a second testcomponent provided in a test path between the second and fourthcontacts, the first and second test components being configured todetect a presence of the unwanted fluid.
 6. The device of claim 1,wherein the contacts are gold-plated.
 7. The device of claim 1, whereinthe first contact is longitudinally offset from the second contact alongthe first surface.